Clinical Research Coordinator B

University of Pennsylvania Perelman School of Medicine

8d•Onsite

About The Position

This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols at the Neurology PAH Parkinson's Disease and Movement Disorders Center. The coordinator will independently manage different phases of complex clinical trials. They will coordinate the screening of patients, subject enrollment, collection and storage of biological samples, updates and maintenance of regulatory documents, and collection and management of clinical data. They will work with the IRB as well as other internal and external partners to ensure that all study documentation is submitted appropriately for initial approval and continuing maintenance. This position will function as lead coordinator on several complex phase I-IV studies. They will coordinate protocol compliance, enrollment and retention of subjects, management of subject visits, management of study drug or devices, and regulatory submissions. This includes recruitment, consent, and screening of patients into the protocol, scheduling subject visits, monitoring and ensuring adherence to protocol requirements, and subject training. They will maintain organized study documentation including source documents, case report forms, subject binders, regulatory binders, and electronic data entry. They will be responsible for collecting, reviewing, and reporting study data, completing data entry, and resolving queries. They will manage all aspects of subject visits including subject training and retention, completion of assessments and questionnaires (PROs), and collection, processing, and shipping of laboratory samples. Assessments may include ECG/EKGs, vital sign collection, cognitive testing, training subjects on study devices or programs, review of medications and medical history, review and reporting of adverse events, etc. This position will participate in study start up, ongoing study maintenance, monitoring, audits, and close out visits. They will attend study team meetings and ongoing protocol training or compliance meetings. They will develop and maintain study specific source documents, regulatory submissions, and regulatory documents/binders. They will review internal budgets, complete research billing, invoice the sponsor, and set up subject payments per budget.

Requirements

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required
Excellent verbal/written communication skills required
Able to work collaboratively on all levels and to gain support of others
Able to confidently interact with all levels of management including senior management, physician leaders and others
Demonstrated complex problem solving abilities
Strong innovative skills
Excellent interpersonal and multi-tasking skills
Must be flexible, detail oriented, and organized
Demonstrated ability to work as part of a team, as well as independently with minimal supervision
Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines.

Nice To Haves

Knowledge of funding policies, NIH, and other grant procedures is desired.

Responsibilities

Facilitate, promote, and ensure good clinical practice in the conduct of all research protocols.
Independently manage different phases of complex clinical trials.
Coordinate the screening of patients, subject enrollment, collection and storage of biological samples, updates and maintenance of regulatory documents, and collection and management of clinical data.
Work with the IRB as well as other internal and external partners to ensure that all study documentation is submitted appropriately for initial approval and continuing maintenance.
Coordinate protocol compliance, enrollment and retention of subjects, management of subject visits, management of study drug or devices, and regulatory submissions.
Recruit, obtain consent, and screen patients into the protocol.
Schedule subject visits.
Monitor and ensure adherence to protocol requirements.
Train subjects.
Maintain organized study documentation including source documents, case report forms, subject binders, regulatory binders, and electronic data entry.
Collect, review, and report study data.
Complete data entry and resolve queries.
Manage all aspects of subject visits including subject training and retention, completion of assessments and questionnaires (PROs), and collection, processing, and shipping of laboratory samples.
Participate in study start up, ongoing study maintenance, monitoring, audits, and close out visits.
Attend study team meetings and ongoing protocol training or compliance meetings.
Develop and maintain study specific source documents, regulatory submissions, and regulatory documents/binders.
Review internal budgets, complete research billing, invoice the sponsor, and set up subject payments per budget.

Benefits

Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
Flexible spending accounts for eligible health care and dependent care expenses with pre-tax dollars
Exceptional tuition benefits for employee, spouse, and dependent children at Penn and other institutions
Generous retirement plans (Basic, Matching, and Supplemental) with pre-tax or Roth basis options
Substantial amount of time away from work
Long-Term Care Insurance
Wellness and Work-life Resources
Professional and Personal Development resources
Access to a wide range of University resources, cultural and recreational activities
Discounts on arts and entertainment, transportation, mortgages, goods and services
Flexible work options
Forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia
Adoption Assistance